Overview
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Description
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
Eligibility
Inclusion Criteria:
- Age ≥70 years unfit or frail
- There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
- Histologically confirmed treatment-naive DLBCL.
- Life expectancy is>3 months.
- appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation
- Adequate bone marrow reserve is defined as:
Hemoglobin ≥8g/dL, platelet count ≥75×10^9/L, Absolute neutrophil value ≥1.0×10^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10^9/L, absolute neutrophil count ≥0.75×10^9/L.
- Patients have the ability to understand and are willing to provide written informed consent.
- Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
Exclusion Criteria:
- Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
- Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
- Uncontrolled active infection;
- Co-existence of other tumors requiring treatment or intervention;
- DLBCL involving central nervous system;
- Current or expected need for systemic corticosteroid treatment;
- Previous or current history of vascular embolism;
- Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
- In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the study.